Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01510431
• Other study ID #: CRD 620
• Status: No longer available

Study information

• Verified date: March 2020
• Source: Mesoblast, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.

The study is not placebo-controlled or randomized.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• currently active moderate-to-severe Crohn's disease

• exhausted standard-of-care options

• age 18 to 70 inclusive

• body weight between 30 and 150 kg

• adequate renal function

• not at risk for tuberculosis (TB) activation or re-activation

Exclusion Criteria:

• biologic therapy for Crohn's within last 8 weeks

• confirmed adverse reactions during prior PROCHYMAL study participation

• alcohol or substance abuse, current or within past 6 months

• active HIV or hepatitis B or C infection

• surgery or trauma with 6 weeks

• allergy to bovine or porcine products

• elevated serum liver enzymes

• elevated serum bilirubin

• active malignancy within 5 years (other than some resected skin cancers)

• bacteremia or other serious bacterial or fungal infection within 3 months

• colonic dysplasia

• unstable arrhythmia or serious heart condition

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• PROCHYMAL (remestemcel-L)
intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	Unviersity of California, San Francisco	San Francisco	California
United States	Stormont-Vail	Topeka	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Mesoblast, Inc.

Country where clinical trial is conducted

United States,